BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 1082464 · Received July 22, 2008

    Report

    Report Number
    1717344-2008-00342
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    July 3, 2008
    Report Date
    July 4, 2008
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE HAS BEEN REQUESTED BUT TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE REPORT STATED THAT DURING A TOTAL HYSTERECTOMY INVOLVING 2 ANNEXECTOMIES THE DEVICE KNIFE WOULD NOT ACTIVATE WHILE SEALING THE LEFT UTERINE ARTERY. THE TISSUE WAS PROPERLY SEALED BUT THE JAWS OF THE DEVICE WOULD NOT OPEN. THERE WAS A DELAY IN SURGERY OF 7 MINUTES. THERE WAS NO BLEEDING OR PATIENT INJURY, ANOTHER DEVICE WAS OPENED AND USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE IMPACT LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 139105

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR